NCT07156864

"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC After Single Administration to Adult Patients".

"Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of the Drug B10-FC - Study Drug for Early Etiotropic Therapy of Coronavirus Infection Caused by the SARS-CoV-2 Virus, Using Heavy-chain Humanized Monoclonal Antibodies, After Single Administration to Adult Patients".

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A two-stage open-label, prospective, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity study with participation of healthy volunteers in three dose-escalation groups and patients with a confirmed diagnosis of COVID-19.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	1/10 therapeutic dose	5 volunteers + 1 replacement volunteer will recieve 1/10 therapeutic dose of the study drug (parenteral administration).
DRUG	1/2 therapeutic dose	5 volunteers + 1 replacement volunteer will recieve 1/2 therapeutic dose of the study drug (parenteral administration).
DRUG	full therapeutic dose	15 volunteers + 3 replacement volunteers will recieve full therapeutic dose of the study drug (parenteral administration).
DRUG	Patients with a verified diagnosis of COVID-19	10 volunteers with a verified diagnosis of COVID-19 will recieve full therapeutic dose of the study drug (parenteral administration).

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-09-05
• Last updated: 2025-09-05